Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

PULMICORT 0.50 mg/ml INHALATION SUSPENSION FOR NEBULIZER

(Budesonide)

Package leaflet contents

1. What Pulmicort 0.50 mg/ml inhalation suspension for nebulizer is and what it is used for
2. What you need to know before using Pulmicort 0.50 mg/ml inhalation suspension for nebulizer
3. How to use Pulmicort 0.50 mg/ml inhalation suspension for nebulizer
4. Possible side effects
5. Storage of Pulmicort 0.50 mg/ml inhalation suspension for nebulizer
6. Contents of the pack and other information

1. What PULMICORT 0.50 mg/ml inhalation suspension for nebulizer is and what it is used for

Pulmicort 0.50 mg/ml is a sterile inhalation suspension intended for use via a nebulizer (an inhalation device). When you breathe through the mouthpiece or mask, the medication reaches the lungs through the inhaled air.

Pulmicort contains budesonide. Budesonide belongs to a group of medicines called glucocorticoids, which are used to reduce inflammation.

Asthma is caused by inflammation of the airways. Budesonide reduces and prevents this inflammation.

Pulmicort 0.50 mg/ml inhalation suspension for nebulizer is used for maintenance treatment of asthma and for the treatment of severe subglottic laryngitis requiring hospitalization. It must be used regularly as directed by your doctor.

2. What you need to know before using PULMICORT 0.50 mg/ml inhalation suspension for nebulizer

Do not use Pulmicort 0.50 mg/ml inhalation suspension for nebulizer:

• if you are allergic to budesonide or to any of the other ingredients of Pulmicort 0.50 mg/ml inhalation suspension for nebulizer.

Warnings and precautions

• If you have or have had pulmonary tuberculosis or any other recent infection.
• If you have ever had liver problems.
• If your doctor has prescribed Pulmicort 0.50 mg/ml and you are currently being treated with cortisone-type tablets, your doctor may gradually reduce the dose of these tablets (over a period of weeks or months), and may eventually discontinue the previous treatment. In such cases, some symptoms such as runny nose, hives, or muscle and joint pain may temporarily reappear. If any of these symptoms concern you, or if you experience others such as headache, fatigue, nausea, or vomiting, contact your doctor.
• Pulmicort has been prescribed for the maintenance treatment of asthma. However, it does not relieve an acute asthma attack once it has started.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children

• If administered to children, your doctor will periodically monitor their growth, as this medicine may cause growth delay.

Consult your doctor if you have any other health problems. Do not use this medicine for other conditions unless directed by your doctor. Never give it to anyone else.

Not all nebulizers are suitable for use with Pulmicort. ULTRASONIC NEBULIZERS MUST NOT be used with Pulmicort 0.50 mg/ml inhalation suspension for nebulizer.

Use of Pulmicort 0.50 mg/ml inhalation suspension for nebulizer with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal remedies. Some medicines may increase the effects of Pulmicort, so your doctor will carry out careful monitoring if you are taking these medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines to treat fungal infections (such as itraconazole and ketoconazole).
• Medicines for HIV (such as ritonavir or cobicistat).
• Cimetidine (a medicine for stomach acidity).

Use in athletes

Athletes are advised that this medicine contains a substance that may result in a positive doping test.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There is no evidence that Pulmicort 0.50 mg/ml inhalation suspension for nebulizer may harm the mother or child when used during pregnancy or breastfeeding. Nevertheless, you should contact your doctor as soon as possible if you become pregnant while being treated with Pulmicort 0.50 mg/ml inhalation suspension for nebulizer.

Pulmicort passes into breast milk, but in minimal amounts that have no effect on the infant.

Use in children

Pulmicort must always be administered under the supervision of an adult to ensure correct administration of the medicine.

Driving and using machines

Pulmicort does not affect your ability to drive or use tools or machinery.

3. How to use PULMICORT 0.50 mg/ml inhalation suspension for nebulizer

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Instructions for use and route of administration

Pulmicort 0.50 mg/ml inhalation suspension for nebulizer must only be used by inhalation via a nebulizer. Do not use ultrasonic nebulizers, as they are not suitable for administering this medicine. Before starting treatment, you must understand how to operate the nebulizer. It is important that you read the information included in the section "How to use Pulmicort 0.50 mg/ml inhalation suspension for nebulizer" and carefully follow the instructions.

Dosage, frequency of administration, and duration of treatment

The dose of Pulmicort must be individualized. Your doctor will adjust the dose and prescribe the lowest amount that controls your asthma or subglottic laryngitis symptoms. Follow your doctor's instructions carefully.

Your doctor will indicate the duration of your Pulmicort treatment. Do not stop treatment prematurely, as this could seriously worsen your condition. Do not take more doses than your doctor has prescribed.

If you feel that the effect of Pulmicort is too strong or too weak, inform your doctor or pharmacist.

Asthma

Recommended initial dose:

Children from 6 months of age: 0.25 – 1 mg per day. In very severe cases, or in children being treated with cortisone-type tablets, a higher initial dose may be given (up to 2 mg daily, equivalent to 2 ampoules). Subsequently, your doctor may consider adjusting the dose necessary. Daily doses of up to 1 mg (1 ampoule) may be administered as a single dose. In cases where the lowest dose is required (0.25 mg/day), 1 ml of Pulmicort 0.25 mg/ml inhalation suspension for nebulizer should be used.

Adults and elderly patients: 1 – 2 mg per day (1 – 2 ampoules per day). In very severe cases, the dose may be increased up to 4 mg (4 ampoules). Subsequently, your doctor may consider adjusting the dose necessary. Daily doses of up to 1 mg (1 ampoule) may be administered as a single dose.

Maintenance dose: When your symptoms have improved, your doctor may decide to reduce your dose to the lowest dose that keeps you symptom-free.

Pulmicort may provide symptom relief within a few days of treatment, although it may take 2 to 4 weeks to achieve full effect. Therefore, it is important that you continue using Pulmicort even when you feel well.

Always remember that Pulmicort has been prescribed for the maintenance treatment of asthma. However, it will not relieve an acute asthma attack once it has started.

Subglottic laryngitis

Infants and children: 2 mg per day (equivalent to 2 ampoules). This may be administered as a single dose or in two 1 mg doses given 30 minutes apart. Administration may be repeated every 12 hours for up to 36 hours or until your doctor considers that your symptoms have improved.

How to use Pulmicort 0.50 mg/ml inhalation suspension for nebulizer

1.- Before use, gently shake to resuspend the contents of the ampoule.

2.- Hold the plastic unit vertically and open by twisting the top wing (see figure).

3.- Slowly pour the contents of the ampoule into the nebulizer reservoir.

The ampoule has a black line indicating a volume of 1 ml when held upside down. If only 1 ml is needed, empty the contents until the surface of the remaining liquid reaches the 1 ml indicator line. Store the opened container protected from light. Opened ampoules must be used within 12 hours. If only 1 ml is used, note that the remaining content is no longer sterile. Gently shake before using the remainder of the suspension.

Note:

Remember to rinse your mouth after each administration. If using a face mask, ensure it fits snugly when inhaling, and remember to wash your face after use.

Cleaning:

The nebulization chamber, mouthpiece, or face mask should be washed after each use with mild detergent and hot water (or as per the manufacturer's instructions). Then rinse thoroughly and dry completely.

If you use more Pulmicort 0.50 mg/ml inhalation suspension for nebulizer than you should

If you accidentally take a single dose of Pulmicort higher than prescribed, harmful effects are unlikely. However, if you use too much Pulmicort over a long period (months), adverse effects may occur. In such a case, consult your doctor or pharmacist immediately.

If you have used more Pulmicort than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and amount used. It is advisable to bring the medicine packaging and leaflet to the healthcare professional.

It is important that you use the dose indicated on the carton (space reserved for the pharmacist) or the dose prescribed by your doctor. Do not increase or decrease your dose without consulting your doctor.

If you forget to use Pulmicort 0.50 mg/ml inhalation suspension for nebulizer

If you forget to take a dose of Pulmicort, do not take a double dose to make up for the missed dose. Continue your treatment as prescribed by your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Adverse effects are usually not experienced during the use of Pulmicort. However, tell your doctor if you experience any of the following adverse effects that are bothersome or do not go away:

Common adverse effects: May affect up to 1 in 10 people

• Mild throat irritation.
• Cough.
• Hoarseness.
• Fungal infection of the mouth and throat.

Uncommon adverse effects: May affect up to 1 in 100 people

• Cataracts (loss of transparency of the eye lens).
• Anxiety.
• Depression.
• Tremors.
• Muscle cramps.
• Blurred vision.

Rare adverse effects: May affect up to 1 in 1000 people

• Allergic-type reactions, including skin rash, contact dermatitis, urticaria, and angioedema (swelling of the face, lips and/or tongue with difficulty swallowing and breathing).
• Skin bruising.
• Behavioural changes (especially in children).
• Restlessness.
• Nervousness.
• As with other inhaled treatments, bronchospasm (i.e., contraction of the airways causing "wheezing") may rarely occur.
• Effects on the adrenal glands (small glands located next to the kidneys).
• Growth retardation.

Adverse effects of unknown frequency that may occur

• Sleep disorders, hyperactivity, or aggressiveness.
• Glaucoma (increased eye pressure).

Inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if high doses are used for a long time. These effects include:

• changes in bone mineral density (reduced bone strength).

These effects are much less likely with inhaled corticosteroids than with oral corticosteroid tablets.

If you were previously being treated with cortisone-type tablets, switching to inhaled corticosteroid treatment may cause the appearance of some symptoms such as fatigue, abdominal pain, weakness, or vomiting. If any of these symptoms occur, consult your doctor immediately.

In rare cases, prolonged treatment with high doses may reduce the growth rate in children, particularly in patients previously treated with cortisone-type tablets or who are especially sensitive.

Facial skin irritation has been observed in some cases when using a nebulizer with a facial mask. To prevent facial irritation, wash the face with water after using the mask.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of PULMICORT 0.50 mg/ml suspension for inhalation by nebulizer

Always keep the sterile ampoules in their aluminium pouch, protected from light.

If you do not use a complete ampoule for one dose, protect it from light.

Store in an upright position.

Do not freeze.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pouch and on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

• Remember the date on which you first opened the pouch. Use the sterile ampoules from a pouch within three months of opening.
• Each sterile ampoule must be used within 12 hours after opening. If you only use 1 ml, note that the remaining contents are no longer sterile.

Medicines must not be disposed of via wastewater or household waste. Take any unused medicines and their packaging to your local pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer

The active substance in Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer is budesonide. Each sterile 2 ml vial contains 1 mg of budesonide. The other components (excipients) are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injection.

Appearance of the product and contents of the pack

Pulmicort 0.50 mg/ml is a sterile suspension intended for inhalation via a nebulizer (inhalation device).

Each pack contains an aluminum foil pouch with 5 sterile 2 ml vials.

There are two concentrations of Pulmicort suspension for inhalation by nebulizer: Pulmicort 0.25 mg/ml suspension for inhalation by nebulizer and Pulmicort 0.50 mg/ml suspension for inhalation by nebulizer.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

AstraZeneca Farmacéutica Spain, S.A.
C/ Puerto de Somport 21-23
28050 Madrid

Manufacturer:

ASTRAZENECA AB
Forskargatan, 18
Södertälje 151 36
Sweden

Date of the most recent revision of this leaflet: November 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/